The Danger in a Demo: How CMS’ Medicare Part B Proposal Could Impede Patient Access to Personalized Medicine

Today, PMC sent a letter to the Centers for Medicare and Medicaid Services (CMS) about their proposal to test new prices for drugs administered under Medicare Part B — a proposal that was developed without input from those who are most directly impacted: patients and physicians.

PMC has a long history of pointing out the unintended consequences of policies under consideration. This one is no different. The plan’s structure fails to account for the fact that one drug is not always equal to another when we are talking about targeted therapy and personalized medicines, which often represent extraordinary medical breakthroughs. These therapies can have an inordinate impact on patient outcomes. Furthermore, because they are only prescribed to the patient populations known to benefit from them, they may help us make better use of our health care dollars in the long term. As such, we should encourage the use of targeted therapies.

In contrast, CMS’ proposal would systematically disadvantage personalized medicine by burdening the most innovative new treatments with the deepest payment cuts. Hospitals and physicians’ offices that cannot adequately offset the cuts may be forced to stop prescribing these therapies to patients. That is a step backward not only for the field, but for medicine itself.

It should be noted that for the past 20 years, personalized medicines were novel — but that is no longer true. Over the past two years and into the foreseeable future, personalized medicines account for about 25% of the new drugs that come to market. This statistic does not account for label changes to existing drugs that indicate better use of them through innovative diagnostics. For patients to benefit from these significant and revolutionary advances in science, we must ensure that our coverage and payment policies support the use of these products and that researchers continue to investigate them.

In other words, for scientific advancement to best serve patient care, we must get policies like this one right.

We urge CMS to carefully design a program that supports innovative, targeted therapies. Personalized medicines treat diseases more effectively. They can improve both quality of life and survival rates. We welcome the opportunity to work with policymakers on this question and suggest that other stakeholders in personalized medicine engage in this conversation as well.

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Launched in July of 2015, Education & Advocacy continues a history of thought leadership that began in 2009 with a blog called The Age of Personalized Medicine. Like the Age blog, Education & Advocacy features commentary by PMC's senior leadership and guest entries from the field's most influential champions. Use the 2009 - 2014 Archives link at the top of this page to access the historical Age blog content and the links below to navigate the content in this blog.